Opioid-use DisorderCoMBAT_OUDNCT04240093
CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
A study testing Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling and Medications for Opioid Use Disorder in people with Opioid-use Disorder and Medication Adherence, run by Brown University at 1 site in United States.
Trial summary
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Medication Adherence, Health Care Utilization
- What is being tested?
- Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling and Medications for Opioid Use Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Initiated medications for opioid use >= 30 day prior to screening
- Current depressive symptoms
- Plans to stay in Rhode Island or Massachusetts for at least 6-months
- Able to read, speak, and understand English
- Willing and able to provide informed consent
Who cannot join
- Does not plan to continue taking medications for opioid use disorder
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview
- In the second or third trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.
Read the detailed description
Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes.
This study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.
- Being tested
- Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling, Medications for Opioid Use Disorder
- Keywords
- Medications for opioid use disorder, Methadone, Buprenorphine, Behavioral Activation
- Medical subject headings
- Opioid-Related Disorders, Medication Adherence, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation (BA) TherapyBehavioural
8 sessions of behavioral activation therapy
Substance Abuse and Health Navigation CounselingBehavioural
2 standard substance abuse and health navigation counseling
Medications for Opioid Use DisorderOther
Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Receives: Behavioral: Behavioral Activation (BA) Therapy; Behavioral: Substance Abuse and Health Navigation Counseling; Other: Medications for Opioid Use Disorder |
| Standard of Care | Active comparator | Substance Abuse and Health Navigation Counseling (2 sessions) + Meds Receives: Behavioral: Substance Abuse and Health Navigation Counseling; Other: Medications for Opioid Use Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Missed Medication Doses - Past 30 Days
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Measured: Baseline, 3 month follow-up, and 6 month follow-up
Number of Missed Medication-related Visits - Past 30 Days
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.
Measured: Baseline, 3 month follow-up, and 6 month follow-up
Secondary outcomes (1)
Fentanyl and Opiate-positive Urine Toxicology Screen
Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)
Measured: Baseline, 3 month follow-up, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Nov 2019
- Primary completion18 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Massachusetts, Boston, National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Jaclyn W Hughto, PhD, MPH, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240093
- Sponsor's protocol ID
- 1906002463
- Other IDs
- Junior Investigator Award, 5P20GM125507-02
- Acronym
- CoMBAT_OUD
- Status last verified
- May 2023
- First submitted
- 21 Jan 2020
- Last updated
- 26 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI) at two different times. The first will be after all of the baseline data is collected. The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze the data, the PI will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PIs' web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04240093
- Acronym / sponsor ID
- CoMBAT_OUD / 1906002463
- Keywords
- Medications for opioid use disorder, Methadone, Buprenorphine, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Boston University, University of Massachusetts, Boston, National Institute of General Medical Sciences (NIGMS), Rhode Island Hospital
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 26 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.
Detailed description
Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes.
This study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Behavioral Activation (BA) Therapy, Behavioral: Substance Abuse and Health Navigation Counseling, Other: Medications for Opioid Use DisorderExperimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds |
| Standard of Care | Active comparator | Behavioral: Substance Abuse and Health Navigation Counseling, Other: Medications for Opioid Use DisorderSubstance Abuse and Health Navigation Counseling (2 sessions) + Meds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Initiated medications for opioid use >= 30 day prior to screening
- Current depressive symptoms
- Plans to stay in Rhode Island or Massachusetts for at least 6-months
- Able to read, speak, and understand English
Key exclusion criteria (4 listed)
- Does not plan to continue taking medications for opioid use disorder
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview
- In the second or third trimester of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation (BA) Therapy8 sessions of behavioral activation therapy | Behavioural | Experimental |
| Substance Abuse and Health Navigation Counseling2 standard substance abuse and health navigation counseling | Behavioural | Experimental, Standard of Care |
| Medications for Opioid Use DisorderMedications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study). | Other | Experimental, Standard of Care |
Primary outcome
Number of Missed Medication Doses - Past 30 Days
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.
Number of Missed Medication-related Visits - Past 30 Days
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.
1 secondary outcome
Fentanyl and Opiate-positive Urine Toxicology Screen
Time frame: Baseline, 3 month follow-up, and 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FRESH Research LabLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI) at two different times. The first will be after all of the baseline data is collected. The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze the data, the PI will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PIs' web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn W Hughto, PhD, MPH principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation (BA) Therapy, Substance Abuse and Health Navigation Counseling and Medications for Opioid Use Disorder in people with Opioid-use Disorder and Medication Adherence, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Missed Medication Doses - Past 30 Days (time frame: Baseline, 3 month follow-up, and 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.